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Tests treatment safety and results for Acute Cerebrovascular Accident
Official title To Assess the Effectiveness and Safety of Catheter-based Focal Intracranial Hypothermia Combined with Endovascular Reperfusion Therapy for Patients with Acute Anterior Circulation Large Artery Occlusion
ClinicalTrials.gov ID: NCT06758609
What this study is testing
What is 4°C saline infusion?
4°C saline infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute cerebrovascular accident.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial to assess the effectiveness and safety of catheter-based focal intracranial hypothermia combined with endovascular reperfusion therapy for patients with acute anterior circulation large artery occlusion.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Age ≥18 and ≤85 years old.
- Symptoms of sudden focal or general neurological impairment.
- There may be a causal relationship between vascular occlusion and nerve function defect.
- Time from symptom onset to randomization ≤24h.
- The National Institutes of Health Stroke Scale (NIHSS) score was ≥6 points before randomization.
You likely can't join if
- Pre stroke mRS\>1 score.
- There are acute infarcts in both cerebral hemispheres and/or anterior and posterior circulation.
- NIHSS≤6 points.
- Cerebral hemorrhage/subarachnoid hemorrhage was confirmed by CT or MRI. 5.The presence of active bleeding, severe anemia, coagulation dysfunction, or...
See the full eligibility criteria
- Age ≥18 and ≤85 years old.
- Symptoms of sudden focal or general neurological impairment.
- There may be a causal relationship between vascular occlusion and nerve function defect.
- Time from symptom onset to randomization ≤24h.
- The National Institutes of Health Stroke Scale (NIHSS) score was ≥6 points before randomization.
- According to the judgment of the clinician, the operation path is reasonable, and the operation and operation related instruments can reach the disease smoothly.
- Patients or their guardians can understand the purpose of the trial, voluntarily participate and sign a written informed consent, and are capable of receiving clinical follow-up.
- Prior to randomization, CTA, MRA, or DSA confirmed the presence of anterior circulatory large vessel occlusion (internal carotid artery or M1segment).
- The symptoms are aggravated by recurrent cerebral infarction in the same drainage basin and/or the pathogenesis is caused by decreased blood perfusion.
- Pre stroke mRS\>1 score.
- There are acute infarcts in both cerebral hemispheres and/or anterior and posterior circulation.
- NIHSS≤6 points.
- Cerebral hemorrhage/subarachnoid hemorrhage was confirmed by CT or MRI. 5.The presence of active bleeding, severe anemia, coagulation dysfunction, or an uncorrected bleeding tendency (Presence of at least one of the...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.